MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. SENSAR; MONOFOCAL IOLS

Model Number	AR40E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: breakdown of 16 events is as follows: haptic damaged 6; haptic detached 4; iol torn 1; lens damaged 5.Serial number of suspect product: (b)(4).10 investigation were completed, and 7 investigations are pending from this period.Breakdown of 10 completed investigations: haptic damaged: 1 lens cut, haptic damaged: 1.Lens cut, haptic detached: 1.No product returned: 7.The investigation concluded that the product met manufacturing release criteria.A review of the records related to the device including complaint trend and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained then a supplemental medwatch will be filed.
Event or Problem Description
This report summarizes 16 malfunction events.The events were related to lens damage.There were no patient injuries reported associated to the events.
Additional Manufacturer Narrative
There are 7 investigations completed during this period.Breakdown of 7 investigations with respective serial numbers are as follows: (b)(6), haptic detached,lens damaged; (b)(6), no product returned; (b)(6), no product returned; (b)(6), no product returned; (b)(6), no product returned; (b)(6), lens cut, haptic damaged,haptic detached; (b)(6), no product returned.The investigations concluded, that product met manufacturing release criteria.And no product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.That was received, during the time period that covers this voluntary malfunction summary report has been submitted.

• Brand Name: SENSAR
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10753189
• Report Number: 2648035-2020-00787
• Device Sequence Number: 3318524
• Product Code: HQL
• UDI-Device Identifier: 05050474502161
• UDI-Public: (01)05050474502161
• Combination Product (Y/N): Y
• PMA/510(K) Number: P980040
• Number of Events Summarized: 16
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00230
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 01/29/2021
• Patient Sequence Number: 1